COVID-19Phase 1NCT04619628
Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19
A Phase 1 study testing COVI-VAC in people with COVID-19, run by Codagenix, Inc at 1 site in United Kingdom.
Trial summary
This is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in healthy adults aged 18 to 30 years. Approximately 48 participants will be enrolled into 1 of 3 dose groups (low, medium, high). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVI-VAC
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Dec 2020to 30 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who meet all of the following criteria may be included in the study:
- Men and women aged between 18 to 30 years of age, inclusive, on the day of signing the informed consent form (ICF)
- In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, hypertension, diabetes, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with subject safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), ECG, spirometry, and safety laboratory tests as determined by the Investigator
- Total body weight of greater or equal to 50 kg and body mass index (BMI) greater or equal to 18.0 kg/m2 and less than or equal to 28.0 kg/m2 (the upper limit of the BMI may be increased to less than or equal to 30 kg/m2 at the Investigator's discretion in case of a muscular healthy subject for whom BMI may be biased upwards)
- Negative drugs of abuse, cotinine, and alcohol screen (unless explained by prescribed medication)
- Negative pregnancy test for women who have not been surgically sterilised
- Negative COVID Clear test
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Haemoglobin A1c ≥6.0% or 42 mmol/mol
- Forced expiratory volume in 1 second (FEV1) less than 80% predicted value
- Signs or symptoms suggestive of upper or lower respiratory tract infection (including fever or persistent cough) within 28 days of Day 1
- Pregnant, possibly pregnant, or lactating women
- Women who have been pregnant through the third trimester or given birth within the past 6 months
Show all 14Show fewer
- Planning a pregnancy (subject or partner) within 90 days after the last IMP dose
- Inadequate venous access for repeated phlebotomy
- History of confirmed or suspected SARS-CoV-2 infection
- Contact with any individual subsequently confirmed to have SARS-CoV-2 within 14 days after contact
- History of wheeze treated with inhaler(s)
- Respiratory symptoms, including wheeze, that have ever resulted in hospitalisation
- Known bronchial hyperreactivity to viruses
- Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month are excluded)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-human, Randomised, Double-blind, Placebo-controlled, Dose-escalation Study in Healthy Young Adults Evaluating the Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Candidate for Prevention of COVID-19
This is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in healthy adults aged 18 to 30 years. Approximately 48 participants will be enrolled into 1 of 3 dose groups (low, medium, high). Within each of these dose groups, participants will be assigned randomly to receive either 2 doses of COVI-VAC 28 days apart, 2 doses of placebo (saline), or 1 dose of COVI-VAC and 1 dose of placebo. COVI-VAC or placebo is administered by drops into each nostril. Neither the participants nor the researchers will know whether COVI-VAC or placebo has been received.
To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 14 days after each dose. Safety laboratory tests, physical exams, ECGs, and a chest X-ray will also be performed, and peak expiratory flow and vital signs will be measured. Adverse events and medication use will be recorded.
Blood samples and intranasal samples will be collected to assess the immune response from the vaccine.
- Conditions
- COVID-19
- Being tested
- COVI-VAC, Placebo
- Keywords
- live attenuated, live attenuated vaccine, SARS-CoV-2, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVI-VACBiological
intranasal, live attenuated vaccine against SARS-CoV-2
PlaceboOther
normal saline
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Normal saline Receives: Other: Placebo |
| Low dose cohort 1 | Experimental | COVI-VAC, single dose Receives: Biological: COVI-VAC |
| Medium dose cohort 1 | Experimental | COVI-VAC, single dose Receives: Biological: COVI-VAC |
| High dose cohort 1 | Experimental | COVI-VAC, single dose Receives: Biological: COVI-VAC |
| Low dose cohort 2 | Experimental | COVI-VAC, two doses 28 days apart Receives: Biological: COVI-VAC |
| Medium dose cohort 2 | Experimental | COVI-VAC, two doses 28 days apart Receives: Biological: COVI-VAC |
| High dose cohort 2 | Experimental | COVI-VAC, two doses 28 days apart Receives: Biological: COVI-VAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactogenicity
Percentage of subjects with reactogenicity events
Measured: 14 days after each dose
Adverse events
Percentage of subjects with adverse events
Measured: Days 1 through 57
Serious adverse events
Percentage of subjects with serious adverse events
Measured: Days 1-400
Secondary outcomes (2)
IgG titre
IgG titre measured by ELISA in serum collected on Days 1, 15, 29, 43, 57, 120, 210, and 400
Measured: Days 1, 15, 29, 43, 57, 120, 210, and 400
Neutralizing antibody titre
Neutralising antibody level measured by microneutralisation assay in serum
Measured: Days 1, 15, 29, 43, 57, 120, 210, and 400
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start11 Dec 2020
- Primary completion26 Jun 2021
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codagenix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daryl Bendel, MD, Principal investigator, Hvivo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619628
- Sponsor's protocol ID
- CDX-CoV-001
- Status last verified
- Jun 2022
- First submitted
- 5 Nov 2020
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human, Randomised, Double-blind, Placebo-controlled, Dose-escalation Study in Healthy Young Adults Evaluating the Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Candidate for Prevention of COVID-19
- ClinicalTrials.gov ID
- NCT04619628
- Acronym / sponsor ID
- CDX-CoV-001
- Conditions
- COVID-19
- Keywords
- live attenuated, live attenuated vaccine, SARS-CoV-2, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Codagenix, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in healthy adults aged 18 to 30 years. Approximately 48 participants will be enrolled into 1 of 3 dose groups (low, medium, high). Within each of these dose groups, participants will be assigned randomly to receive either 2 doses of COVI-VAC 28 days apart, 2 doses of placebo (saline), or 1 dose of COVI-VAC and 1 dose of placebo. COVI-VAC or placebo is administered by drops into each nostril. Neither the participants nor the researchers will know whether COVI-VAC or placebo has been received.
To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 14 days after each dose. Safety laboratory tests, physical exams, ECGs, and a chest X-ray will also be performed, and peak expiratory flow and vital signs will be measured. Adverse events and medication use will be recorded.
Blood samples and intranasal samples will be collected to assess the immune response from the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Other: PlaceboNormal saline |
| Low dose cohort 1 | Experimental | Biological: COVI-VACCOVI-VAC, single dose |
| Medium dose cohort 1 | Experimental | Biological: COVI-VACCOVI-VAC, single dose |
| High dose cohort 1 | Experimental | Biological: COVI-VACCOVI-VAC, single dose |
| Low dose cohort 2 | Experimental | Biological: COVI-VACCOVI-VAC, two doses 28 days apart |
| Medium dose cohort 2 | Experimental | Biological: COVI-VACCOVI-VAC, two doses 28 days apart |
| High dose cohort 2 | Experimental | Biological: COVI-VACCOVI-VAC, two doses 28 days apart |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who meet all of the following criteria may be included in the study:
Key exclusion criteria (14 listed)
- Haemoglobin A1c ≥6.0% or 42 mmol/mol
- Forced expiratory volume in 1 second (FEV1) less than 80% predicted value
- Signs or symptoms suggestive of upper or lower respiratory tract infection (including fever or persistent cough) within 28 days of Day 1
- Pregnant, possibly pregnant, or lactating women
- Women who have been pregnant through the third trimester or given birth within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVI-VACintranasal, live attenuated vaccine against SARS-CoV-2 | Biological | High dose cohort 1, High dose cohort 2, Low dose cohort 1, Low dose cohort 2, Medium dose cohort 1, Medium dose cohort 2 |
| Placebonormal saline | Other | Saline |
Primary outcome
Reactogenicity
Time frame: 14 days after each dose
Percentage of subjects with reactogenicity events
Adverse events
Time frame: Days 1 through 57
Percentage of subjects with adverse events
Serious adverse events
Time frame: Days 1-400
Percentage of subjects with serious adverse events
2 secondary outcomes
IgG titre
Time frame: Days 1, 15, 29, 43, 57, 120, 210, and 400
Neutralizing antibody titre
Time frame: Days 1, 15, 29, 43, 57, 120, 210, and 400
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daryl Bendel, MD principal investigator
Hvivo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVI-VAC in people with COVID-19, run by Codagenix, Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactogenicity (time frame: 14 days after each dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.